An Exploratory Study of RGT Strategy on Optimal NUC-experienced Patients
A Prospective, Randomized, Multicenter, Open-label, Exploratory Study of Utilizing of "Response-Guided-Therapy (RGT)" Strategy on Optimal Nucleoside Analogue (NUC)-Experienced Patients
1 other identifier
interventional
324
0 countries
N/A
Brief Summary
The aim of current study is to investigate whether the HBsAg clearance rate can be improved if applying RGT((Response-Guided Therapy) strategy in HBeAg positive CHB(chronic hepatitis B) patients treated by nucleoside analogue(NUC) achieved HBVDNA\<1000copies/ml，and HBsAg\<5000IU/ml; \&HBeAg\<100PEIU/ml (or470s/co), combined with PEG-IFN a-2a for 24 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 22, 2015
CompletedFirst Posted
Study publicly available on registry
September 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedSeptember 25, 2015
September 1, 2015
1.3 years
September 22, 2015
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants who achieve HBsAg clearance
To investigate whether HBsAg clearance rate can be improved at week 48 following applying RGT strategy(week 24) in NUC-experience subjects will be measured by the number of participants who achieve HBsAg clearance
Week 48
Secondary Outcomes (11)
Number of participants who achieve HBsAg seroconversion
Week 48
Number of participants who achieve HBeAg loss
Week 48
Number of participants who achieve HBeAg seroconversion
Week 48
Percentage of of participants who achieve HBsAg decline >2log from baseline(0 week)
Week 48
Percentage of of participants who achieve HBsAg <10IU/mL
Week 48
- +6 more secondary outcomes
Study Arms (3)
A:PEG+NUC (HBsAg<200IU/ml at week 24)
EXPERIMENTALPeginterferon alfa-2a 180μg /wk plus nucleoside analogue(NUC): HBsAg\<200IU/ml at week 24 (Following treatment with Peginterferon alfa-2a plus nucleoside analogue(NUC) for 24 weeks)
B:PEG+NUC(HBsAg>200IU/ml at week 24)
ACTIVE COMPARATORPeginterferon alfa-2a 180μg /wk plus+nucleoside analogue(NUC): HBsAg\>200IU/ml at week 24 (Following treatment with Peginterferon alfa-2a plus nucleoside analogue(NUC) for 24 weeks)
C:NUC(HBsAg>200IU/ml at week 24)
ACTIVE COMPARATORnucleoside analogue(NUC): HBsAg\>200IU/ml at week 24 (Following treatment with Peginterferon alfa-2a plus nucleoside analogue(NUC) for 24 weeks)
Interventions
Peginterferon alfa-2a 180μg /wk plus Entecavir 0.5mg qd for 48 weeks(Arm A and B)
Peginterferon alfa-2a 180μg /wk plus Lamivudine 0.1g qd for 48 weeks(Arm A and B)
Peginterferon alfa-2a 180μg /wk plus Adefovir 10mg qd for 48 weeks(Arm A and B)
Peginterferon alfa-2a 180μg /wk plus Tenofovir 300mg qd for 48 weeks(Arm A and B)
Entecavir 0.5mg qd for 24 weeks(Arm C)
Lamivudine 0.1g qd for 24 weeks(Arm C)
Adefovir 10mg qd for 24 weeks(ArmC)
Tenofovir 300mg qd for 24 weeks(Arm C)
Eligibility Criteria
You may qualify if:
- Male and female patients with age ≥18 and ≤65 years;
- There should be evidences that HBsAg and HBeAg have been positive for more than 6 months with HBsAb and HBeAb negative before treated with nucleoside analogue(NUC) (except of telbivudine);
- Treated with NUC (except of telbivudine)for more than 24 weeks and achieve HBV DNA\<1000copies/ml and HBsAg\<5000IU/ml；\&HBeAg\<100PEIU/ml(470s/co);
- Without contra-indications to Peginterferon alfa-2a therapy as detailed in the label;
- Without co-infection with hepatitis C, hepatitis D and HIV;
- Women without ongoing pregnancy or breast feeding and willing to take an effective contraceptive measure during the treatment
- Agree to participate in the study and sign the patient informed consent form.
You may not qualify if:
- Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV)
- AFP(alpha fetoprotein)\>50ng/ml and/or evidence of hepatocellular carcinoma
- Evidence of decompensated liver disease (Child-Pugh scores \>5). Child-Pugh \>5 means that, if one of the following 6 conditions is met, the patient has to be excluded:
- Serum albumin \<35 g/L
- Prothrombin time prolonged≥ 4 seconds or PTA(prothrombin activity) \< 60%
- Serum bilirubin \> 34 µmol/L
- History of encephalopathy
- Ascites
- History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia)
- Pregnant or breast-feeding Women
- ANC(absolute neutrophil count)\<1.5x 10\^9/L or PLT(platelet count)\<90x 10\^9/L
- Consuming alcohol in excess of 20g/day for women and 30g/day for men within 6 months prior to enrollment
- History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as major depression or psychosis that treated with antidepressant medication or a major tranquilizer at therapeutic doses respectively at any time prior to 3 months or any history of the following: a suicidal attempt hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
- History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.)
- History of esophageal varices bleeding or other evidence of esophageal varices bleeding or other symptoms consistent with decompensated liver disease
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Related Publications (3)
Ning Q, Han M, Sun Y, Jiang J, Tan D, Hou J, Tang H, Sheng J, Zhao M. Switching from entecavir to PegIFN alfa-2a in patients with HBeAg-positive chronic hepatitis B: a randomised open-label trial (OSST trial). J Hepatol. 2014 Oct;61(4):777-84. doi: 10.1016/j.jhep.2014.05.044. Epub 2014 Jun 7.
PMID: 24915612BACKGROUNDP. Hu et al. 2015 EASL abstract O116. PREDICTIVE VALUE OF BASELINE AND ON-TREATMENT qHBsAg LEVEL IN HBeAg POSITIVE CHB PATIENTS WHO SWITCHED FROM NUCS TO PEGYLATED INTERFERON A-2A: A FURTHER ANALYSIS FROM NEW SWITCH STUDY
BACKGROUNDBrouwer WP, Xie Q, Sonneveld MJ, Zhang N, Zhang Q, Tabak F, Streinu-Cercel A, Wang JY, Idilman R, Reesink HW, Diculescu M, Simon K, Voiculescu M, Akdogan M, Mazur W, Reijnders JG, Verhey E, Hansen BE, Janssen HL; ARES Study Group. Adding pegylated interferon to entecavir for hepatitis B e antigen-positive chronic hepatitis B: A multicenter randomized trial (ARES study). Hepatology. 2015 May;61(5):1512-22. doi: 10.1002/hep.27586. Epub 2015 Feb 27.
PMID: 25348661BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of infectious disease
Study Record Dates
First Submitted
September 22, 2015
First Posted
September 25, 2015
Study Start
May 1, 2015
Primary Completion
August 1, 2016
Study Completion
February 1, 2017
Last Updated
September 25, 2015
Record last verified: 2015-09